510(k) K862119

DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR by Parke-Davis Co. — Product Code DYG

K862119 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on August 29, 1986. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Parke-Davis Co. has at least 10 other 510(k) clearances on record.